MalfunctionDPW
QUANTIX/OR
Received Dec 2, 2004 · Event occurred Nov 29, 2004
Report 3003596523-2004-00001 · MDR key 558348
Device
Generic name
Blood Flowmeter
Manufacturer
Cardiosonix, Ltd.Model number
4210Catalog number
CSN 00210
Lot number
*
Product problems
- Fluid/Blood Leak
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
DISTRIBUTOR'S REP REPORTED THAT FOLLOWING CLEANING AND SOAKING AS DESCRIBED IN THE PRODUCT'S USER MANUAL, THE PROBE WAS LEAKING FLUID FROM UNDER THE COVER SHEET OF THE PROBE HANDLE; APPROXIMATELY 20-30 DROPS.
Remedial action
- Notification
- Relabeling